Clinical trial of adult stem cells in heart attack reports on safety and efficacy
Posted Jan 13 2010 10:09pm
SLOWLY Catching Up…
Phase I trial of bone marrow stem cells in patients who had suffered a myocardial infarction. Safety was good and patients receiving the stem cell injections appeared to recover better.
The results of a Phase I trial looking at outcomes for heart attack patients treated with adult stem cells have concluded that the treatment is safe and should go forward to Phase II efficacy trials.
53 patients from ten centers across the USA
received one of three doses of bone marrow stem cells or placebo
a purified formulation of mesenchymal stem cells
injected intravenously into the leg or arm within 10 days of the heart attack
patients were then monitored over 2 years to assess any side effects and recovery was measured using a variety of imaging techniques, measures of heart function and symptom scores.
“The results point to a promising new treatment for heart attack patients that could reduce mortality and lessen the need for heart transplants,” commented Gary Schaer, principal investigator at Rush University.
There was no evidence of any increase in adverse events in the stem cell- versus placebo-treated patients. Hematological parameters and markers of kidney and liver function were not different between the groups. Patients receiving stem cells showed greater improvement in symptoms, better heart function and fewer arrhythmias than patients receiving placebo after 6 months. There was also evidence of better lung function in the treatment group.
These results, recently published in the Journal of the American College of Cardiology, were considered sufficiently positive to proceed to a Phase II efficacy trial, which is currently recruiting.
“It is suspected that these stem cells may take part in the growth of new blood vessels to bring more oxygen to the heart and help reduce the scarring from a heart attack,” stated Dr Schaer.
The cells used in this study were mesenchymal stem cells harvested from the bone marrow of healthy unrelated adult donors. The researchers involved in the study feel that mesenchymal stem cells have advantages for clinical use in that they do not provoke immune reaction, are easy to prepare and have been extensively tested for this indication in animal studies.
“This study suggests that adult bone marrow derived stem cells are more flexible than previously thought … if the benefits and safety are confirmed in the ongoing Phase II trial, we may soon have a remarkable new therapy.”